Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. In a biologic drug, the active ingredient is known as a bulk process intermediate (BPI).
Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma and cancer.
The information provided in the download document is drafted for pharmaceutical executives, research and development (R&D) executives, quality control and quality assurance executives, as well as API manufacturers, distributors, suppliers, sales managers, process engineers, technicians, research associates and production chemists, and any other individuals involved in the operations of the API and active pharmaceutical intermediates industry.
The download contains detailed information on API manufacturers to aid in purchasing decisions, including product ranges and contact details.
Types of active pharmaceutical ingredients
APIs are broadly categorised into two types – synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used.
Synthetic chemical APIs, also known as small molecules, constitute a large part of the pharmaceutical market, with many small molecule drugs commercially available in the market.
Natural APIs are used in making biologics, which are increasingly becoming the top-selling drugs in the market. Despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.
Based on the solubility, APIs are categorised into insoluble and soluble drugs.
Top active pharmaceutical ingredients and intermediates suppliers
Pharmaceutical Technology has listed the leading suppliers of active pharmaceutical ingredients and intermediates based on its intel, insights and decades-long experience in the sector. The list includes companies that can develop and supply high-quality pharmaceutical materials, including, but not limited to:
- Fine chemicals and intermediates, such as high-docosahexaenoic acid oil for API production
- APIs for central nervous system therapies
- Natural cannabinoid (CBD) ingredients, CBD isolates and cannabis distillates
- Excipients
- Insulin for cell culture media
- Ammonium compounds
- Mineral salts
The list also includes suppliers of mixing and drying technologies, polymer coatings for drug delivery, extraction technologies for high-purity APIs, and dispersion and wet milling technology. Providers of automatic capsule filling machines, dry powder and liquid-based material handling systems, analytic services for biological assays, pharma tablet manufacturing machines, and custom synthesis services are detailed in the document as well.
For full details (including contact details) on the leading companies within this space, download the free Buyer’s Guide below:
Frequently asked questions
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What are Active Pharmaceutical Ingredients (APIs)?
Active Pharmaceutical Ingredients (APIs) are the biologically active components in medications responsible for producing the intended therapeutic effects. They are meticulously developed and manufactured to ensure efficacy, safety, and quality in treating various health conditions. In the case of biologic drugs, these active components are often referred to as bulk process intermediates (BPIs).
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How are APIs Manufactured?
The production of APIs involves sophisticated chemical synthesis processes, which may include multiple stages of reaction, purification, and crystallisation to achieve the desired purity and potency. Manufacturers must adhere to stringent Good Manufacturing Practices (GMP) to maintain high-quality standards and ensure patient safety. This includes rigorous testing and validation at each step of the production process.
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What is the Role of Intermediates in API Production?
Intermediates are chemical compounds that serve as precursors in the synthesis of APIs. They are formed during the multi-step process of API production and are further processed to become the final active ingredient. The quality and purity of intermediates are crucial, as they directly impact the efficacy and safety of the final pharmaceutical product.
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Why is Quality Assurance Important in API Manufacturing?
Quality assurance in API manufacturing is vital to ensure that the active ingredients meet the required standards for purity, potency, and safety. This involves comprehensive testing for impurities, consistent production processes, and compliance with international regulatory standards. Effective quality assurance prevents contamination, ensures batch-to-batch consistency, and upholds the therapeutic efficacy of the medications.
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How Do APIs Impact the Pharmaceutical Industry?
APIs are fundamental to the pharmaceutical industry as they determine the effectiveness of medications. The development and supply of high-quality APIs enable pharmaceutical companies to produce safe and effective drugs for various therapeutic areas. Advancements in API synthesis and manufacturing technologies also contribute to the development of new treatments and the improvement of existing therapies, thereby enhancing patient outcomes globally.